Fracture Risk Prompts Experts to Recommend Bisphosphonate Changes

Experts are recommending that doctors change the way they prescribe bisphosphonates like Fosamax, in light of recent research indicating the osteoporosis drugs may be associated with serious thigh fractures. The changes impact not only who may be treated with bisphosphonates in the future, but how long patients will take them.

In addition to Fosamax, bisphosphonates include Aclasta, Actonel, Aredia, Bondronat, Boniva, Didronel, , Fosavance, Reclast, Skelid, and Zometa. Last year, the U.S. Food & Drug Administration (FDA) asked the manufacturers of bisphosphonates to add information to the â€œWarnings and Precautionsâ€ section of the drugs’ labels describing the risk of atypical thigh fractures. The FDA’s action was prompted by a study of more than 300 women who had suffered subtrochanteric (just below the hip joint) or diaphyseal femur (breaks in the long part of the thigh bone) fractures found that 94 percent had taken bisphosphonates for osteoporosis, and most had been on the drugs for five years or more.

Earlier this week, we reported that a Swedish study had confirmed this risk. The study, published in the May 4 issue of the New England Journal of Medicine, looked at 12,777 women aged 55 and older who suffered a fracture of the thigh bone in 2008. Seventy-eight percent of those with the atypical femoral fractures were on bisphosphonates, while only 10 percent who suffered other types of thigh fractures were taking the drugs. The study also found that the women who took the drugs the longest faced the highest risk, while the fracture risk was reduced when patients stopped taking the drugs.

According to a report in USA Today, Ken Lyles, director of geriatrics research at Duke University, said considering findings, bisphosphonate patients should discuss a “drug holiday” with their doctors. Lyles, who is also a member of the American Society of Bone and Mineral Research (ASBMR), said bisphosphonates can be taken intermittently after several years, he says.

Lyles and other experts are also now advising against prescribing Fosamax and similar drugs to treat osteopenia, unless other risk factors for fractures – a history of falls, low body mass index, smoking and excessive drinking – exist. Osteopenia is a condition that causes lower-than-normal bone mass, and is often considered a precursor to osteoporosis, USA Today said.

According to USA Today, Lyles and fellow ASBMR member Douglas Kiel, a professor at Harvard University, will discuss these issues this weekend at the annual conference of the American Geriatrics Society.